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The purpose of this study is to determine how efficient the combination of rituximab, cyclophosphamide, vincristine, and prednisolone (R-CVP) is in the treatment of stage I or II non-conjunctival ocular adnexal MALT lymphoma (OAML).
Full description
The treatment of stage I or II OAML is mainly composed of radiotherapy because chemotherapy including cyclophosphamide, vincristine, and prednisolone (CVP) did not show the acceptable response rate compared with radiotherapy. However, radiotherapy for this disease can cause many complications of eyes. This clinical trial was designed to examine the efficacy of R-CVP combination therapy as a first-line treatment for stage I or II non-conjunctival OAML aiming to avoid radiation hazard and increase the efficacy of CVP chemotherapy.
Enrollment
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Volunteers
Inclusion criteria
Histologically confirmed OAML
Non-conjunctival or bilateral conjunctival (TNM-based, above T1N0M0 or bT1N0M0), Ann Arbor stage I and II OAML
Previously untreated
Age ≥18 years
Performance status: ECOG 0-2
Adequate hematological function: hemoglobin ≥9 g/dL,, absolute neutrophil count (ANC) ≥1,500/μL, and platelet count ≥100,000/μL, unless abnormalities are due to bone marrow involvement by the lymphoma
Adequate liver function tests:
i. Transaminase (AST/ALT) <3 times the upper normal value ii. Bilirubin <2 times the upper normal value
Adequate renal function:serum creatinine level <2 mg/dL (177 μmol/L)
Life expectancy ≥ 6 months
A negative serum or urine pregnancy test before treatment must be available for both premenopausal women and for women who have <2 years after the onset of menopause.
Informed consent
Exclusion criteria
NHL subtypes other than OAML
Primary conjunctival OAML, unilateral involved (T1N0M0)
Ann Arbor stage III or IV
CNS involvement by the lymphoma or any evidence of spinal cord compression. Brain CT/MRI is only mandatory (within 4 weeks) with clinical suspicion of CNS involvement by the lymphoma
Pregnant or lactating women, women of child-bearing potential not using adequate contraception
Inadequate liver function tests:
i. Transaminase (AST/ALT) ≥3 times the upper normal value or ii. Bilirubin ≥2 times the upper normal value
Inadequate renal function:
i. serum creatinine level <2 mg/dL (177 μmol/L)
Other serious illness or medical conditions i. Unstable cardiac disease despite treatment; myocardial infarction within 6 months prior to study entry ii. History of significant neurological or psychiatric disorders including dementia or seizures
Active uncontrolled infection (HIV, hepatitis B, Hepatitis C, active Tuberculosis, active bacterial, or active fungal infection)
Any other malignancies within the past 5 years except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
Known hypersensitivity to any of the study drugs or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies)
Concomitant administration of any other experimental drug under investigation or concomitant chemotherapy, hormonal therapy, or immunotherapy
Primary purpose
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Interventional model
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33 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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